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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Xsert Lumbar Expandable Interbody System - M697T0920600101

16mm x 10mm x 24mm TRIAL
Xtant Medical Holdings, Inc.
T092-0600-10
In Commercial Distribution

  • M697T0920600100 ()
  • M697T0920600101 ()

  • Length: 24 Millimeter
  • Width: 10 Millimeter
  • Height: 16 Millimeter


  • Metallic spinal interbody fusion cage

Aranax Anterior Cervical Plating System - M697T08615281

TWO-LEVEL PLATE TEMPLATE, 28 mm
Xtant Medical Holdings, Inc.
T086-1528
In Commercial Distribution

  • M697T08615280 ()
  • M697T08615281 ()

  • Length: 28 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Axle Interspinous Fusion System - M697T08038281912TR1

Irix A 38 x 28 x 19mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-12TR
In Commercial Distribution

  • M697T08038281912TR0 ()
  • M697T08038281912TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281908TR1

Irix A 38 x 28 x 19mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-08TR
In Commercial Distribution

  • M697T08038281908TR0 ()
  • M697T08038281908TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Angle: 8 degree


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281712TR1

Irix A 38 x 28 x 17mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-12TR
In Commercial Distribution

  • M697T08038281712TR0 ()
  • M697T08038281712TR1 ()

  • Angle: 12 degree
  • Width: 38 Millimeter
  • Height: 17 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281708TR1

Irix A 38 x 28 x 17mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-08TR
In Commercial Distribution

  • M697T08038281708TR0 ()
  • M697T08038281708TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281512TR1

Irix A 38 x 28 x 15mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-12TR
In Commercial Distribution

  • M697T08038281512TR0 ()
  • M697T08038281512TR1 ()

  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281508TR1

Irix A 38 x 28 x 15mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-08TR
In Commercial Distribution

  • M697T08038281508TR0 ()
  • M697T08038281508TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281312TR1

Irix A 38 x 28 x 13mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-12TR
In Commercial Distribution

  • M697T08038281312TR0 ()
  • M697T08038281312TR1 ()

  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 12 degree


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281308TR1

Irix A 38 x 28 x 13mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-08TR
In Commercial Distribution

  • M697T08038281308TR0 ()
  • M697T08038281308TR1 ()

  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 8 degree
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile
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